Systems and Methods for Anti-Microbial Effect for Bones

ABSTRACT

Systems and methods for restructure and stabilization of bones that provide an anti-microbial effect are disclosed herein. A device includes a delivery catheter having an inner void for passing at least one light sensitive liquid, and an inner lumen; an expandable member releasably engaging the distal end of the delivery catheter; at least one channel positioned in the expandable member; and a light conducting fiber sized to pass through the inner lumen of the delivery catheter and into the expandable member, wherein, when the light conducting fiber is in the at least one channel, the light conducting fiber is able to disperse light energy to provide an anti-microbial effect. When the light conducting fiber is in the expandable member, the light conducting fiber is able to disperse the light energy to initiate hardening of the light sensitive liquid within the expandable member to form a photodynamic implant.

RELATED APPLICATIONS

This application is a continuation patent application of U.S.application Ser. No. 16/263,125, filed Jan. 31, 2019, which is acontinuation patent application of U.S. application Ser. No. 15/343,738,filed Nov. 4, 2016, now U.S. Pat. No. 10,226,642, which claims thebenefit of and priority to U.S. Provisional Application No. 62/272,420,filed Dec. 29, 2015 and to U.S. Provisional Application No. 62/252,275,filed Nov. 6, 2015. The contents of each of these applications areincorporated herein by reference in their entireties.

FIELD

The embodiments disclosed herein relate to bone implants, and moreparticularly to systems and methods providing an anti-microbial effectfor bones.

BACKGROUND

Bones form the skeleton of the body and allow the body to be supportedagainst gravity and to move and function in the world. Bone fracturescan occur, for example, from an outside force or from a controlledsurgical cut (an osteotomy). A fracture's alignment is described as towhether the fracture fragments are displaced or in their normal anatomicposition. In some instances, surgery may be required to re-align andstabilize the fractured bone. A bone infection may occur when bacteriaor fungi invade the bone, such as when a bone is fractured or from bonefracture repair. These bacteria commonly appear and if not addressedproperly can cause server health problems. It would be desirable to havean improved systems and methods for stabilizing, positioning, andrepairing a fractured or weakened bone that further includes eliminatingbacteria.

SUMMARY

System and methods for providing an anti-microbial effect on a bone aredisclosed. According to aspects of the disclosed subject matter, asystem for providing an anti-microbial effect on a bone comprising: adelivery catheter having an elongated shaft with a proximal end, adistal end, and a longitudinal axis therebetween, an inner void forpassing at least one light sensitive liquid, and an inner lumen; anexpandable member releasably engaging the distal end of the deliverycatheter, the expandable member capable of moving from a deflated stateto an inflated state by infusing at least one light sensitive liquidinto the expandable member; and a light conducting fiber sized to passthrough the inner lumen of the delivery catheter and into the expandablemember, wherein, when the light conducting fiber is in the expandablemember, the light conducting fiber is able to initiate hardening of theat least one light sensitive liquid within the expandable member to forma photodynamic implant and the light conducting fiber is able todisperse light energy to provide an anti-microbial effect to the bone.

According to aspects of the disclosed subject matter, a system forproviding an anti-microbial effect on a bone comprising: a deliverycatheter having an elongated shaft with a proximal end, a distal end,and a longitudinal axis therebetween, an inner void for passing at leastone light sensitive liquid, and an inner lumen; an expandable memberreleasably engaging the distal end of the delivery catheter, theexpandable member trial fits into a space within a bone by alternatinglymoving from a deflated state to an inflated state and back to thedeflated state only by at least one light sensitive liquid, when the atleast one light sensitive liquid is passed in and out of the expandablemember, one or more channels in the expandable member; and a lightconducting fiber sized to pass through the inner lumen of the deliverycatheter and into the at least one channel in the expandable member,wherein, when the light conducting fiber is in the one or more channels,the light conducting fiber is able to disperse light energy to providean anti-microbial effect to the bone.

According to aspects of the disclosed subject matter, a system forrestructuring or stabilizing of bones that provides an anti-microbialeffect. The system includes a delivery catheter having an elongatedshaft with a proximal end, a distal end and a longitudinal axis therebetween. The delivery catheter includes an inner void for passing atleast one light sensitive liquid and also includes an inner lumen. Anexpandable member releasably engaging the distal end of the deliverycatheter, the expandable member trial fits into a space within a bone byalternatingly moving from a deflated state to an inflated state and backto the deflated state only by at least one light sensitive liquid, whenthe at least one light sensitive liquid is passed in and out of theexpandable member. The expandable member is designed to be at leastpartially placed into the space within the bone, and directly in contactwith the bone and to form fit to a surface contact area within the spaceof the bone. A light conducting fiber sized to pass through the innerlumen of the delivery catheter and into the expandable member, wherein,when the light conducting fiber is in the expandable member, the lightconducting fiber is able to disperse light energy to provide ananti-microbial effect prior to infusing the at least one light sensitiveliquid in the expandable member. Infusing the at least one lightsensitive liquid in the expandable member, wherein the at least onelight sensitive liquid is passed in and out of the expandable member toform fit to the surface contact area within the space of the bone.Wherein, when the light conducting fiber is in the expandable memberinitiate hardening of the at least one light sensitive liquid within theexpandable member to form a photodynamic implant. Wherein, an amount ofthe light sensitive liquid is hardened within the trial fittedexpandable member, such that a size and a shape of the formedphotodynamic implant has a size and a shape of the space inside thebone, so the bone is restructured to a substantially original size andan original shape around the formed photodynamic implant.

According to aspects of the disclosed subject matter, the systemincluding a cavity in the expandable member includes at least onechannel, such that the light conducting fiber is configured to pass intothe at least one channel and provide the anti-microbial effect fromwithin the at least one channel.

According to aspects of the disclosed subject matter, a method forproviding an anti-microbial effect on a bone comprises gaining access toa cavity in a bone; delivering in an unexpanded state, an expandablemember having at least one channel to the cavity in the bone; infusingthe at least one light sensitive liquid in the expandable member to movethe expandable member from a deflated state to an inflated state;positioning an optical fiber sufficiently designed to emit light energyalong a length of the optical fiber inside the at least one channel inthe expandable member; activating a light source engaging the opticalfiber; and delivering light energy from the light source to the opticalfiber to providing an anti-microbial effect on a bone.

The method may further comprise curing the light-curable fluid insidethe balloon to harden the expandable member. The method may furthercomprise prior to the step of infusing the at least one light sensitiveliquid in the expandable member, the step of: positioning the opticalfiber inside the at least one channel in the expandable member;activating the light source; delivering light energy to the opticalfiber from the light source; and removing the optical fiber from the atleast one channel in the expandable member.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1A shows a schematic illustration of an embodiment of a boneimplant system of the present disclosure. The system includes a lightsource, a light pipe or multiple light pipes, an attachment system, alight-conducting fiber(s), a light-sensitive liquid, a delivery catheterand an expandable member sufficiently shaped to fit within the confinesof the medullary canal or other spaces, cavities or gaps in a fracturedbone, according to an embodiment of the disclosure;

FIG. 1B and FIG. 1C show schematic illustrations of embodiments of abone implant device that includes a delivery catheter and an expandablemember sufficiently shaped to fit within a space, cavity or a gap in afractured bone, according to embodiments of the disclosure;

FIG. 2A and FIG. 2B show close-up cross-sectional views of the regioncircled in FIG. 1A. FIG. 2A shows a cross-sectional view of a distal endof the delivery catheter and the expandable member prior to the devicebeing infused with light-sensitive liquid. FIG. 2B shows across-sectional view of the distal end of the delivery catheter and theexpandable member after the device has been infused with light-sensitiveliquid and light energy from the light-conducting fiber is introducedinto the delivery catheter and inner lumen of the expandable member tocure the light-sensitive liquid, according to embodiments of thedisclosure;

FIG. 2C and FIG. 2D show a close-up cross-sectional view of the regionscircled in FIG. 1B and FIG. 1C, respectively. FIG. 2C and FIG. 2D eachshow a cross-sectional view of a distal end of the delivery catheter andthe expandable member and a light-conducting fiber in the deliverycatheter and inner lumen of the expandable member, according toembodiments of the disclosure;

FIG. 3 shows a view of an embodiment of a distal end of a ballooncatheter in commutation with expandable member, which comprises aninflatable balloon having at least one channel located in the inflatableballoon approximate an outer surface of the inflatable balloon for atleast one optic fiber to enter there through, according to embodimentsof the disclosure;

FIG. 4 shows ridges located on an outer surface of the balloon of theexpandable member, wherein the ridges include at least one channel forthe optical fibers to enter there through, according to embodiments ofthe disclosure;

FIG. 5 shows a channel or channels configured with at least one or morereflective prisms, i.e. magnification devices, for magnifying light fromthe optical fibers, according to embodiments of the disclosure;

FIG. 6 shows a ridge or ridges configured to include at least one ormore reflective prisms, i.e. magnification devices, according toembodiments of the disclosure;

FIG. 7A and FIG. 7B show at least one manifold located within at leastone lumen of the expandable member, wherein the at least one lumen ofthe expandable member is in communication with the one or more channelslocated within the expandable member as shown in FIG. 3. FIG. 7A shows amanifold located at a proximal end of the expandable member. FIG. 7Bshows a manifold located in a lumen at a distal area of the expandablemember, according to embodiments of the disclosure;

FIG. 8A, FIG. 8B and FIG. 8C show views of a distal end of a devicehaving a removable cap for repairing a weakened or fractured bone of thepresent disclosure, according to embodiments of the disclosure;

FIG. 9 shows an embodiment of an optical fiber of the present disclosurefabricated from a flexible light transmitting material that can beinserted into at least one channel, according to embodiments of thedisclosure;

FIG. 10 shows a view of another embodiment of a distal end of a ballooncatheter of the present disclosure, which is similar to FIG. 3, whereinthe optical fiber has a pre-defined shape specific to the shape of thechannel, according to embodiments of the disclosure;

FIG. 11A, FIG. 11B, FIG. 11C, FIG. 11D and FIG. 11E provide embodimentmethods for delivering light and/or implanting an intramedullary implantof the present disclosure within the intramedullary space of a weakenedor fractured bone, according to embodiments of the disclosure;

FIG. 12 illustrates the results of Experiment 1, that shows the output(Blue), positive control (405 nm—orange), positive control (470nm—gray), wherein box area highlights the wavelengths of light (405 nmto 470 nm) that has shown to be antimicrobial against orthopaedicrelevant bacteria. The blue light has a major peak in the region of 405nm;

FIG. 13A and FIG. 13B illustrate the results of Experiment 1, that showsthe initial suspension culture experiments were conducted demonstratinga time-dependent killing of MSSA with the light at energy levels thatare not toxic to mammalian cells;

FIG. 14A, FIG. 14B, FIG. 14C, FIG. 14D, FIG. 14E, FIG. 14F, and FIG. 14Gshow the initial experimental set up;

FIG. 15A, FIG. 15B, FIG. 15C, FIG. 15D, FIG. 15E, FIG. 15F, FIG. 15G,FIG. 15H, FIG. 15I, FIG. 15J, FIG. 15K, FIG. 15L, FIG. 15M, FIG. 15N,FIG. 15O, and FIG. 15P show the optical fiber (POF) experimental set up;

FIG. 16A is a graph that shows the spectral output from the fiber opticcable used in the device, according to embodiments of the disclosure;

FIG. 16B and FIG. 16C show the blue light output from the site ofhumeral biopsy, according to embodiments of the disclosure;

FIG. 17A shows a graph of the number of the patient isolated MRSAculture counts versus time in seconds curing with the blue light,according to embodiments of the disclosure and

FIG. 17B shows the percent decrease in colony counts versus time inseconds curing with the blue light, according to embodiments of thedisclosure.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

Systems and methods for bone fixation procedures are disclosed herein.In some embodiments, devices and methods including stabilization andproviding an anti-microbial effect for bone restructuring are disclosed.An anti-microbial effect may also include a bactericidal effect or ananti-bacterial effect, among other things.

A medical device disclosed herein may be used for treating conditionsand diseases of the bone, including, but not limited to, the femur,tibia, fibula, humerus, ulna, radius, metatarsals, phalanx, phalanges,ribs, spine, vertebrae, clavicle and other bones and still be within thescope and spirit of the disclosed embodiments.

Overview

According to embodiments of the present disclosure, the device, systemand methods disclosed provide, among other things, a site specifictreatment approach to target a specific infection area within a bone.For example, in some embodiments, the site specific treatment approachis designed to provide treatment in the endosteal, i.e. inside surfaceof the bone, so as to treat infection in the bone from the medullarycanal, i.e. from the inside to the outside. This is contrast totreatments using antibiotics to fight infection; the treatment used ofantibiotics results in a systemic broad approach towards treating theinfection, which is not a targeted site specific treatment as per theinstant disclosure. For example, after an invasive surgical procedure aninfection may develop in the patient, requiring the patient to undergoantibiotic treatment. Treatments using antibiotics are delivered eitherorally or by infusion, wherein such broad treatment goes towards anentire anatomical treatment of the body. For example, even during thecourse of this broad treatment using antibiotics, the specific area ofthe actual infection may not be properly treated and/or as a result thisbroad treatment likely will deliver more drugs than is required to treatthe specific infection area or mall area. The present disclosure isdirected to a site specific approach by applying light to the specificinfection area to kill the infected matter or bacteria. The aspects ofthe present disclosure results in, providing direct treatment to theinfection area, using only an amount of treatment necessary to kill theinfection, i.e. which is in contrast to the broad treatment approach ofusing antibiotics. Further, the use of light to treat infection of thepresent disclosure results in only may be in an additional small amountof antibiotic as a “clean-up” that may be required. Further, at leastone aspect of the site specific treatment results in a faster “kill” ortermination of the infection versus the broad treatment approach ofusing the systematic drug, i.e. antibiotics.

According to embodiments of the present disclosure, the device, systemsand methods disclosed provide an anti-microbial effect on bones.

According to embodiments of the present disclosure, the device, systemsand methods disclosed provide a bactericidal effect on bones.

According to embodiments of the present disclosure, the device, systemsand methods disclosed provide an anti-bacterial effect on bones.

According to embodiments of the present disclosure, the device, systemsand methods disclosed provide an anti-infective effect on bones.

According to embodiments of the present disclosure, the device, systemand methods disclosed provide for an application of light to kill theinfection which creates the formation and transfers energy to molecularoxygen, thus forming the reactive singlet oxygen. This oxidizing speciescan destroy proteins, lipids, and nucleic acids causing cell death andtissue necrosis. The instant disclosure's application of light createsmolecular oxygen, thus forming the reactive porphyrins. For example,during treatment, electromagnetic radiation having wavelengths in thevisible spectrum (i.e., visible light above 395 nm, by non-limitingexample) reacts with naturally produced and/or concentrated “endogenous”chromophores (porphyrins). At least one effect of the application of theelectromagnetic radiation (illumination) is that the light inconjunction with or in combination with the porphyrins produces necrosisor cell death to the bacteria as evidenced by the microorganism'sinability to divide. It is noted that the application of treatment ofthe instant disclosure provides treatment without the addition ofancillary drugs or chemicals, which can be considered as a “holistic”killing treatment or approach to fighting infection.

According to embodiments of the present disclosure, the device, systemand methods disclosed provide for an application that can be used as aself-standing instrument to “wand” the canal of the bone or as a part ofa balloon (with monomer) to both stabilize and kill the infection, i.e.providing a site specific treatment approach. It is possible thattreatment for an infection within a canal of the bone may only includeusing a balloon placed within the canal and merely introducing theapplication of light disclosed in the present disclosure to treat orkill the infection area. For example, the use of the balloon can provideat least one benefit, in that the expanded balloon acts as filler withinthe canal compressing and causing the remaining medullary canalmaterials to be displaced and putting the balloon in direct appositionto the medullary canal wall. Whereby, the results of the application ofthe balloon within the medullary canal allow for an environment for anappropriate transmission or application of light to kill bacteria in theinfection area. For example, failure to displace the medullary canalmaterials would result in an occluded canal, which would be preclusiveto light meeting the bone walls or endosteal surface, thus failure intreating the infection area.

Further, at least one benefit of the use of light in accordance with thepresent disclosure may include the termination of newer and morevirulent strains of drug resistant bacteria, i.e. “super bugs”.Traditional antibiotic methods of killing infections using antibioticfails to kill virulent strains of drug resistant bacteria, i.e. “superbugs. Traditional antibiotic methods kill using a chemical and biologicresponse associated with O2, i.e. necrosis and cell inability to divideand replicate. As noted above, the present disclosure incorporates theapplication of light which causes the formation of porphyrins, whereinthe application of electromagnetic radiation (illumination) inconjunction with or in combination with the porphyrins, producesnecrosis or cell death to the bacteria as evidenced by themicroorganism's inability to divide. Further, as noted above, theapplication of electromagnetic radiation (illumination) according thepresent disclosure presents a treatment of the infection area frominside the bone to outward.

Illumination Providing an Antimicrobial Effect within Cavities of theBone

FIG. 1A is a schematic illustration showing various components of anembodiment of a system 100 of the present disclosure. The system 100includes a light source 108, a light pipe 120, an attachment system 130and a light-conducting optical fiber 106 having a nonlinearlight-emitting portion 158, which emits light from the outside of theoptical fiber 106 along its length. The attachment system 130communicates light energy from the light source 108 to the optical fiber106. In an embodiment, the light source 108 emits frequency thatcorresponds to a band in the vicinity of 350 nm to 770 nm, the visiblespectrum. In an embodiment, the light source 108 emits frequency thatcorresponds to a band in the vicinity of 380 nm to 500 nm. In someembodiments, the light source 108 emits frequency that corresponds to aband in the vicinity of 430 nm to 450 nm. In some embodiments, the lightsource 108 emits frequency that corresponds to a band in the vicinity of430 nm to 440 nm.

The system 100 includes emitting a beam of a blue light or violet-bluelight within a cavity of the bone via an optical fiber for bothilluminating towards polymerization as well as towards providing anantimicrobial effect. For example, light from a light source can be usedto kill micro-bacteria located within a cavity of a bone before, duringand after the healing process of the fractured bone. Steps to kill themicro-bacteria in the cavity of the bone can include emitting the beamof blue light or violet-blue light having a wavelength from about 380 nmto about 500 nm. For example, in some embodiments, the beam of bluelight or violet-blue light can have a wavelength from about 400 nm toabout 470 nm, including, for example, about 436 nm. However, it will beappreciated in view of this disclosure that, in some embodiments, theblue light/beam may have a wavelength from about 350 to about 500 nm,about 350 to about 550 nm, about 350 nm to about 600 nm, about 350 nm toabout 650 nm, about 350 nm to about 700 nm, about 350 nm to about 750nm, or about 350 nm to about 770 nm. For example, in some embodiments,the blue light/beam may have a wavelength of about 405 nm, about 380 nm,about 436 nm, or about 470 nm.

Still referring to FIG. 1A, the beam of blue light/beam can delivervariable energy densities to bone walls of the cavity of the bone, whichcan increase the temperature, i.e. bone walls of the cavity of the bone,while emitting the blue fight/beam. The steps of emitting the bluelight/beam within the cavity of the bone may be completed without: (1)exposing the bone walls to further evasive surgical procedures due toantimicrobial effect related treatments; (2) the need for applyingantimicrobial type liquids or related applications; and (3) the need ofremoving the killed micro bacteria from the affected area.Micro-bacteria may be defined, by non-limiting example, as anopportunistic microorganism. For example, a bacterium, virus, fungus orthe like, that takes advantage of certain opportunities to causedisease, i.e. those opportunities can be called opportunisticconditions. These microorganisms are often ones that the human immunesystem cannot raise an adequate response, such these microorganisms caneventually overwhelm the body's weakened defenses.

For example, according to at least one aspect of the disclosure, it iscontemplated to kill micro bacteria that may have an opportunity toexist or already exists within the cavity of the bone. The use of theblue light/beam can include many variables when treating an affectedarea, by non-limiting example, the blue light/beam may incorporate manycombination of aspects when being applied to an affected area such as:(1) variable energy densities, conceptually by altering the wave form onthe light liber it is possible to emit more or less light in differentand specific areas—and similarly alter the temperature on a local levelor site specific area; (2) variable generated temperature(s) at aspecific location within the affected area; (3) variable exposure timeemitted to the affected area; (4) variable distance of the opticalfiber's distal end to the affected area; and (5) a pulsing or constantblue light/beam emitted or a combination thereof, among other things.

Still referring to FIG. 1A, the instant disclosure may additionallyinclude step or steps of incorporating variable temperatures such ascooling an affected area (before, during or after treatment), so thatthe bone wall temperature along the blue light/beam emission does notexceed a temperature that may result in irreversible damage to the bonewalls of the cavity of the bone. It is contemplated that possiblycooling vents may be used in the process so as to pulse a coolingliquid, i.e. water, through channels to cool the implant and thesurround tissue. It is also possible that to fill the balloon with asuper cooled material so as to necrose or freeze the biofilm, i.e.bacterial colony, through an overall thermal effect and in conjunctionwith the blue light. By non-limiting example, the bone wall temperaturealong the blue light/beam emission may be contemplated not to exceed atemperature of about 42° C. or between 40° C. to 45° C. It iscontemplated that a super cooled device may be used so that theapplication necroses tissue.

Further, the energy emitted by the blue light/beam may be termed inportions of joules (i.e. radiant energy), joules per cubic meter (i.e.radiant energy density), watts (i.e. radiant flux), watt per meter andwatt per hertz (i.e. spectral flux), watt per steradan (i.e. radiantintensity), or the like.

It is noted that in the application of light to kill bacteria and tohave success it is likely dependent upon a variety of factors, not theleast of which, may be intensity as defined by joules or (watts)intensity multiplied by time. Further, the polymerization andantimicrobial effects are not the same, i.e. at the same time, ordependent. Such that, where polymerization can be the marriage of aknown frequency light to a known monomer, i.e. photo initiator, with aspecified time toward polymerization, the successful ability to killbacteria may require a higher energy deposition than required to cure.It may be possible to circumvent a need to apply non-clinically relevanttimes, more light, i.e. energy that may need to be applied. Among otherthings, a possible solution may be to attempt to use higher energy andillumination sources. The limitations in the transference andlimitations to the amount of energy may be transported down the fiber.

Among other things, laser light has a limitation, such that energy needsto be dispersed over a wide area and the light needs, unlike an endfire, needs to be transmitted. Further, laser light, which is intense,requires the need to “bleed it off” or disperse it in a fashion over theentire length of the implant, wherein the process of doing so reducesthe mw of light energy. Further still, with reduction of the intensity,and mw being a byproduct of implant length, the exposure area requirestime to increase. At some point the increased time is no longerclinically relevant, such that when increased to a point where it'slonger by some degree, as compared to that of the curing of the implant.

The optical fiber 106 used in the system 100 can be made from anymaterial, such as glass, silicon, silica glass, quartz, sapphire,plastic, combinations of materials, or any other material, and may haveany diameter. Further, the optical fiber 106 can be made from apolymethyl methacrylate core with a transparent polymer cladding. Itshould be noted that the term “optical fiber” is not intended to belimited to a single optical fiber, but may also refer to multipleoptical fibers as well as other means for communicating light from thelight source to the expandable member. It is possible the fibers, afterexciting the light source, may be twisted so as to form into a singlefiber. Further, the optical fiber may comprise of a single fiber at alocation that is in combination with multiple fibers at anotherlocation. It is possible, the multiple fibers positioned at the otherlocation may be further incorporated into another single fiber at yet atanother location within the system, i.e. the method of using the lightfiber may be a single or multiple fibers or any variation thereof.

Light Source

Still referring to FIG. 1A, it is contemplated the light source mayinclude a single bulb or multiple bulbs, wherein the light source mayfurther include one or multiple ports to attach light fibers. The lightfibers or light guides may be joined, mixed or include some combinationthereof, within the system. Depending upon the application, the lightsource can be designed to provide higher outputs in differentfrequencies, i.e. using multiple bulbs, so as to overcome potential falloff aspects that may occur using a single bulb. If multiple bulbs areused, it is contemplated that there may be multiple types of bulbs usedin the system. For example, each different type of bulb may provide aspecific attribute to meet an intended design aspect for the particularapplication, which may include attributes relating frequency ranges,energy density ranges, operation life expectancies, etc. Further,regarding other elements within the system where multiple elements ofthe same element are used, i.e. light fibers (optical fibers, lightguides, etc.), light conductive materials and the like, it iscontemplated that there may be different types of the same element usedwithin the system. As noted above, each different type of element may beused depending upon the specific attribute to meet an intended designaspect for the particular application, which may include attributesrelating material type(s), performance related ranges, operation lifeexpectancies, etc. In conjunction with choosing a specific element, anymaterials and elements used with that specific element may be furtherused, so as to meet the intended planned design for the particularapplication. For example, it is contemplated a clear liquid epoxy may beused to bind and fill in interstices of multiple fibers towards a smoothtube or the like, with the system.

Delivering Light to Cavities of the Bone

Referring to FIG. 1A, FIG. 1B, FIG. 1C and FIG. 2A and FIG. 2B, for thesystem to deliver the light to the cavity of the bone, the system 100further includes a balloon catheter 110 having an elongated shaft 101with a proximal end 102, a distal end 104, and a longitudinal axis therebetween. In an embodiment, the balloon catheter 110 can have an outsidediameter ranging from about 3 mm (9 French) to about 8 mm (24 French).However, it is noted the balloon catheter 110 may have an outsidediameter of about 3 mm (9 French). At least one inner lumen isincorporated within the elongated shaft 101 of the balloon catheter 110.The elongated shaft 101 of the balloon catheter 110 may include twoinner lumens. The elongated shaft 101 of the balloon catheter 110 mayinclude three inner lumens, four inner lumens or more. It iscontemplated the one or more inner lumens may accept one or more opticalfibers. The proximal end 102 of the balloon catheter 110 includes anadapter for passage of at least one of inflation fluids or medicalinstruments.

The distal end 104 of the balloon catheter 110 includes at least oneexpandable member 170. The expandable member 170 of FIG. 1A has abulbous shape; however, the expandable member 170 may have any othersuitable shape. It is possible, the at least one expandable member 170includes multiple expandable members. For example, the distal end 104 ofthe balloon catheter 110 may include a first inner inflatable balloonpositioned inside and completely surrounded by an outer inflatableballoon. In an embodiment, the expandable member 170 can be manufacturedfrom a non-compliant (non-stretch/non-expansion) conformable material.In an embodiment, the expandable member 170 is manufactured from aconformable compliant material that is limited in dimensional change byembedded fibers. One or more radiopaque markers, bands or beads may beplaced at various locations along the expandable member 170 and/or theballoon catheter 110 so that components of the system 100 may be viewedusing fluoroscopy.

FIG. 1B and FIG. 1C show schematic illustrations of embodiments of abone implant device. The devices include a balloon catheter 110 and anexpandable member 170 sufficiently shaped to fit within a space, cavityor a gap in a fractured bone. It is contemplated the expandable membermay be of any shape so as to fit within a space, cavity or a gap in afractured bone. For example, the expandable members 170 of FIG. 1B andFIG. 1C can have a tapered elongated shape to fill the space, cavity orgap in certain fractured or weakened bones to be repaired or stabilized.In an embodiment, the expandable member 170 can have an antegrade shapeas shown in FIG. 1B. In an embodiment, the expandable member 170 canhave a retrograde shape as shown in FIG. 1C. In FIG. 1B, the expandablemember 170 can have a larger diameter at its distal end than theproximal end. In FIG. 1C, the expandable member 170 can have a largerdiameter at its proximal end than the distal end.

In the embodiments shown in FIG. 1A, FIG. 1B, and FIG. 1C, the proximalend of the balloon catheter 110 includes a first port 162 and a secondport 164. The first port 162 can accept, for example, thelight-conducting fiber 140 or multiple light-conducting fibers. Thesecond port 164 can accept, for example, a syringe 160 housing alight-sensitive liquid 165. In an embodiment, the syringe 160 maintainsa low pressure during the infusion and aspiration of the light-sensitiveliquid 165. In an embodiment, the syringe 160 maintains a low pressureof about 10 atmospheres or less during the infusion and aspiration ofthe light-sensitive liquid 165. In an embodiment, the syringe 160maintains a low pressure of less than about 5 atmospheres during theinfusion and aspiration of the light-sensitive liquid 165. In anembodiment, the syringe 160 maintains a low pressure of about 4atmospheres or less during the infusion and aspiration of thelight-sensitive liquid 165. In an embodiment, the light-sensitive liquid165 is a photodynamic (light-curable) monomer. In an embodiment, thephotodynamic (light-curable) monomer is exposed to an appropriatefrequency of light and intensity to cure the monomer inside theexpandable member 170 and form a rigid structure.

FIG. 2A and FIG. 2B show close-up cross-sectional views of the regioncircled in FIG. 1. FIG. 2A shows a cross-sectional view of a distal endof the balloon catheter 110 and the expandable member 170 prior to thedevice being infused with light-sensitive liquid. FIG. 2B shows across-sectional view of the distal end of the balloon catheter 110 andthe expandable member 170 after the device has been infused withlight-sensitive liquid and light energy from the light-conducting fiberis introduced into the balloon catheter 110 and inner lumen of theexpandable member 170 to cure the light-sensitive liquid.

As illustrated in FIG. 2A and FIG. 2B, the flexible balloon catheter 110includes an inner void 152 for passage of the light-sensitive liquid165, and an inner lumen 154 for passage of the light-conducting fiber140. In the embodiment illustrated in FIG. 2A and FIG. 2B, the innerlumen 154 and the inner void 152 are concentric to one another. Thelight-sensitive liquid 165 has a low viscosity or low resistance toflow, to facilitate the delivery of the light-sensitive liquid 165through the inner void 152. In an embodiment, the light-sensitive liquid165 has a viscosity of about 1000 cP or less. In an embodiment, thelight-sensitive liquid 165 has a viscosity ranging from about 650 cP toabout 450 cP. The expandable member 170 may be inflated, trial fit andadjusted as many times as a user wants with the light-sensitive liquid165, up until the light source 110 is activated, when the polymerizationprocess is initiated. Because the light-sensitive liquid 165 has aliquid consistency and is viscous, the light-sensitive liquid 165 may bedelivered using low pressure delivery and high pressure delivery is notrequired, but may be used.

FIG. 2C and FIG. 2D show a close-up cross-sectional view of the regioncircled in FIG. 1B and FIG. 1C, respectively. FIG. 2C and FIG. 2D showcross-sectional views of a distal end of the balloon catheter 110 andthe expandable member 170 and a light-conducting fiber 140 with a cut141 in the fiber in the balloon catheter 110 and inner lumen of theexpandable member 170. The device also has a separation area 172 at thejunction of the balloon catheter 110 and the expandable member 170 wherethe balloon catheter 110 may be separated from the expandable member170.

Channels within the Expandable Member for the Optical Fibers

FIG. 3 shows a view of another embodiment of a distal end of a ballooncatheter of the present disclosure. The distal end of the ballooncatheter includes expandable member 170, which comprises an inflatableballoon 301. The inflatable balloon 301 has a wall with an outer surface305 and an inner surface 330. The inner surface 330 defines an innercavity 335.

Further, at least one channel 303A is located in the cavity 305 of theinflatable balloon 301 approximate the inner surface 330 of theinflatable balloon 301. The balloon catheter includes an elongated shafthaving a first inner lumen 311 in fluid communication with theexpandable balloon 301 which is also in communication with the at leastone channel 303A. A separate optical fiber 306 can be incorporatedwithin the elongated shaft of the balloon catheter and encircle theinner surface of the expandable balloon 303A within the at least onechannel 303A.

Further, the elongated shaft of the balloon catheter includes a secondinner lumen 313 in fluid communication with the expandable balloon 301,wherein another channel (not shown) or multiple channels (not shown) maybe incorporated. For example, the additional channels may be used foradditional optical fibers that can be incorporated within the elongatedshaft of the balloon catheter and encircle the inner surface(s) of theexpandable balloon 303A. It is possible that, the channel or channelsmay be shaped longitudinally within the expandable member, wherein theremay be 1, 2, 3, 5, 8 or more longitudinal channels extending from oneend to another end of the expandable member. It is possible that alongitudinal channel or channels may be inter-connected with one or moreother channels, so that an optical fiber or multiple optical fibers mayextend there through. The longitudinal channel may be linear, non-linearor some combination thereof extending from one end to another end of theexpandable member.

In an embodiment, the channel or channels may be spiral shaped withinthe expandable member, wherein there may be 1, 2, 3, 5, 8 or more spiralchannels. It is possible that a spiral shaped channel or channels may beinter-connected with one or more other channels, so that an opticalfiber or multiple optical fibers may extend there through. The spiralshaped channel or channels may be linear, non-linear or some combinationthereof. At least one aspect, by non-limiting example, among otherthings, is that the channel or channels can be configured to provide amaximum amount of light to the bone walls within the cavity of the bone.At least one benefit, among other things, of a spiral configuration isthe large amount of light provided.

Ridges Located on an Outer Surface of Expandable Member Having at LeastOne Channel for the Optical Fibers

FIG. 4 shows ridges 309 located on an outer surface 305 of the balloon301 of the expandable member 170, wherein the ridges 309 include atleast one channel 303B for the optical fibers 306 to enter therethrough. The distal end of the balloon catheter includes expandablemember 170, with the inflatable balloon 301 includes an inner lumen 311and one or more ridge 309 located the outer surface 305 of theinflatable balloon 301, wherein at least one or more channel 303B islocated within the one or more ridge 309. The ridge 309 can beconfigured to incorporate at least one or more channel 303B for at leastone or more optical fiber 306, such that the at least one or moreoptical fiber 306 is capable of entering and exiting the at least one ormore channel 303B.

The ridge or ridges 309 may be shaped longitudinally along an outersurface of the expandable member, wherein there may be 1, 2, 3, 5, 8 ormore longitudinal ridges 309 extending from one end to another end ofthe expandable member 170. It is possible that a longitudinal ridges 309may be inter-connected with other ridges 309, so that an optical fiberor multiple optical fibers 306, i.e. within the channel's 303B of theridges 309, may extend there through. The longitudinal ridges 309 may belinear, non-linear or some combination thereof extending from one end toanother end of the expandable member.

In an embodiment, the ridge or ridges 309 may be spiral shaped withinthe expandable member 170, wherein there may be 1, 2, 3, 5, 8 or morespiral ridge or ridges 309. It is possible that a spiral shaped ridge orridges 309 may be inter-connected with one or more other channels, sothat an optical fiber or multiple optical fibers 306 may extend therethrough. The spiral shaped ridge or ridges 309 may be linear, non-linearor some combination thereof. At least one aspect, by non-limitingexample, among other things, is that the ridge or ridges 309 can beconfigured to provide a maximum amount of light to the bone walls withinthe cavity of the bone.

The ridges that include channels are configured to provide access forpassing optic fibers to pass there through and within the cavity of thebone; either prior to, during the delivery of the light-sensitiveliquid, or after the light-sensitive liquid has been cured and hardened.It is contemplated the optical fiber(s) may provide for an antimicrobialeffect while light-sensitive liquid is infused through the inner void210 in the delivery catheter 101 and enters the inner cavity 295 of theexpandable member 170.

Channels Having One or More Reflective Prisms, i.e. MagnificationDevices, for Magnifying Light from the Optical Fibers

FIG. 5 is similar to and includes the elements of FIG. 3, however, FIG.5 shows a channel or channels 303A configured with at least one or morereflective prisms 317, i.e. magnification devices, for magnifying lightfrom the optical fibers. The reflective prisms may include reflectiveprism arrays, reflective prism assemblies and the like, wherein thereflective prisms can be located along the channels 303A, 303B, and/orat an end of the channels 303A, 303B. The reflective prism can be usedto reflect light, in order to flip, invert, rotate, deviate or displacethe light beam from the optical fiber. For example, the reflective prismmay comprise of different types of materials, including reflective tape,among other things.

Ribs Having One or More Reflective Prisms, i.e. Magnification Devices,for Magnifying Light from the Optical Fibers

FIG. 6 is similar to and includes the elements of FIG. 4, however, FIG.6 shows a ridge or ridges 309 configured to include at least one or morereflective prisms 318, i.e. magnification devices. The reflective prismsmay include reflective prism arrays, reflective prism assemblies and thelike, wherein the reflective prisms can be located along the ridge orridges 309, and/or at an end of the ridge or ridges 309. The reflectiveprism can be used to reflect light, in order to flip, invert, rotate,deviate or displace the light beam from the optical fiber.

Manifold Incorporated within an End of Expandable Member for AllowingAccess to Channels for the Optical Fibers

FIG. 7A and FIG. 7B show at least one manifold 344, 346 located withinat least one lumen of the expandable member 170.

FIG. 7A is similar to and includes the elements of FIG. 2C, however,FIG. 7A shows the manifold 344 in communication with the at least onelumen of the expandable member 170 and in communication with the one ormore channels (not shown) located within the expandable member 170 asshown in FIG. 3. The manifold 344, by non-limiting example, can provideaccess for one or more light-conducting fiber 306 to enter the at leastone lumen of the expandable 170 and through the manifold 344 and furtherinto the channels located within the expandable member 170. The manifold344 is configured to provide access for passing optic fibers 306 withinthe cavity of the bone; either prior to, during the delivery of thelight-sensitive liquid, or after the light-sensitive liquid has beencured and hardened.

Still referring to FIG. 7A shows the manifold 344 located at a proximalend of the expandable member 170. For example, the manifold 344 may belocated within a lumen of the expandable member 170 from about an end ofthe separation area 172 closest to the proximal end of the expandablemember 170 to the proximal end of the expandable member 170 (see FIG. 2Cand FIG. 2D). The manifold 344 of FIG. 7A may be utilized by firstaccessing the flexible balloon catheter first port with thelight-conducting fiber (see FIG. 1A, FIG. 1B, and FIG. 1C), then passingthe light-conducting fiber through the inner lumen (see FIG. 2A and FIG.2B), through the a distal end of the balloon catheter and into theseparation area 172 (see FIG. 2C and FIG. 2D), then into at least onelumen of the expandable member to enter into the manifold 344.

FIG. 7B shows a manifold 346 located in a lumen at a proximal area 212of the expandable member 170. Wherein, the manifold 346 of FIG. 7B maybe utilized by entry through the flexible balloon catheter, however, themanifold 346 may be utilized by the optical fiber entering the distalend 214 of the expandable member 170.

Regarding FIG. 7A and FIG. 7B, the manifold 344, 346 may comprise of aflexible material, a non-flexible material or some combination thereof.The manifold 344, 346 may comprise of two or more openings that connectwith two or more channels located within the expandable member.

Removable Cap to Seal Lumens of Expandable Member

FIG. 8A, FIG. 8B and FIG. 8C show views of a distal end of a devicehaving a removable cap for repairing a weakened or fractured bone of thepresent disclosure.

It is contemplated the removable cap may be used after the lightsensitive liquid has been cured, wherein the hardened expandable memberis formed into a formed photodynamic implant. For example, it ispossible the formed photodynamic implant may have a removable cap thatseals the lumen from fluids and/or other tissue from entering, thuskeeping the lumen clean, as well as the light intensity in the future isnot diminished. It is possible the central lumen may include areceptacle for at least one rod that may be used to fill the lumen, suchthat screws on the end of the implant may be designed and/or intended tokeep the lumen clean and optically transparent. Further, lumen can beaccessed in the future by a removal of the cap, and the rod or the capmay have a valve or access point to allow a minimally invasive means topost operatively introduce the light source. Further still, the cap mayhave a valve and/or access port that can be accessed in a minimallyinvasive fashion. It is possible that a small percutaneous needle may beused, where the fiber is introduced through the cap, and/or the fibermay lead in to it. The cap and implant end can be designed to guide andsteer the fiber into the lumen. It is possible that there may be aconical end that acts as a recipient. Further, the cap can be of aradiopaque material that it can be located by x-ray.

FIG. 8A is a view of an embodiment of a distal end 114 of the flexibledelivery catheter 101. The distal end 114 includes the expandable member170 releasably mounted on the flexible delivery catheter 101. Theexpandable member 170 has a wall 202 with an outer surface 205 and aninner surface 230. The inner surface 230 defines an inner cavity 235. Insome embodiments, the delivery catheter 101 may include multiple innerlumens or voids. For example, as shown in FIG. 8A, the delivery catheter101 may include an outer tube 209 and a central tube 220 concentricallydisposed within the delivery catheter 101. An inner void 210 may beformed between the outer tube 209 and the central tube 220. The innervoid 210 may be utilized for passing a light-sensitive liquid into theinner cavity 235 of the expandable member 170. In some embodiments, thecentral tube 220 includes an inner lumen 211 for passing alight-conducting fiber (which is not illustrated in FIG. 2) into theexpandable member 170 to cure the light sensitive liquid inside theinner cavity 235 of the expandable member, as described in detail below.It should be noted that while the delivery catheter 101 is described ashaving the central lumen 220 concentric with the outer tube 209, thecentral lumen 220 may be off-set relative to the outer tube 209.

The expandable member 170 includes a proximal area 212 and a distal area214. The proximal area 212 of the expandable member 170 is releasablyconnected to the delivery catheter 101. The distal area 214 may beconnected to the delivery catheter 101 in a variety of ways.

In reference to FIG. 8B, in some embodiments, the distal area 214 of theexpandable member 170 may be connected to a distal cap 300. The distalcap 300 terminates and seals off the area 214 (or lumen) of theexpandable member 170 to prevent the flow of a light-sensitive liquidoutside the balloon and the ingress of bodily fluids inside the balloon.One potential benefit of utilizing the distal cap 300 is ease ofmanufacture and more consistent tip quality when compared to traditionalmelt forming of expandable member 170 directly to the delivery catheter.An additional benefit of the use of the distal cap 300 may also includethe ability to reflect back or scatter light radiating from the end ofthe conducting fiber to improve the light-sensitive liquid cure times ordepth of cure. The reflected light from the distal cap 300 may increasethe energy that is directed towards the light-sensitive liquid in theexpandable member 170 and thus may increase the photo-initiation rate(and thus polymerization rate) of the light-sensitive liquid.

In some embodiments, the distal cap 300 may be formed, molded ormachined from an implant grade polymer (e.g., PET), or anotherbiocompatible material. The distal cap 300 may also be made from afilled material. For example, the PET polymer may be blended with aradiopaque material (e.g., barium sulfate, tungsten, tantalum, etc.)such that the distal cap 300 may be viewed with the assistance offluoroscopic imaging. In some embodiments, the distal cap 300 may alsobe covered with a reflective material such as a gold film (or othermetallic highly polished implant grade film) to enable the distal cap300 to reflect light radiating from the end of the light pipe back intothe balloon. This reflected light can help to reduce the cure time ofthe light sensitive liquid contained within the expandable member 170 todue to the increase in light energy directed at the light sensitiveliquid. In some embodiments, the distal cap 300 may also be fabricatedfrom a crystalline material (such as crystalline PET) to block thetransmission of light through the end of the device 100 and to reflectand/or scatter the light back to the light sensitive liquid in theexpandable member 170.

As illustrated in FIG. 8B, a distal cap 300 includes a body 302 having aproximal end 304 and a distal end 321. The body 302 defines an innercompartment 303 wherein at least one manifold (not shown) may optionallybe positioned. The distal cap 300 may stabilize the at least onemanifold and may minimize movement of the at least one manifold duringthe operation. It is possible the at least one manifold may be securedinside the compartment 303 by press fitting the at least one manifoldinto the compartment 303; applying permanent adhesive on the surfacesbetween the at least one manifold and the compartment 303; melt bondingthe two surfaces together or other techniques.

FIG. 8B and FIG. 8C show the distal end 321 of the body 302 may beeither open or closed. In some embodiments, the distal cap 300 closesthe distal tip 321 of the body 302 to close the distal tip 321. Thedistal cap 300 includes an inner surface 309, which faces the body 302,and an outer surface 310, which faces away from the body 302. In someembodiments, the outer surface 310 of the distal cap 300 may be roundedor smooth to provide the device 100 with an atraumatic distal point. Insome embodiments, the distal cap 300 may have a semi-circular shape witha flat inner surface and a curved outer surface.

In reference to FIG. 8B, in some embodiments, the material forming theexpandable member 170 may be attached to the outer surface of the body302. In some embodiments, the outer surface of the body 302 includesrecessed attachment sections 312 a, 312 b to which the material of theexpandable member 170 can be attached. In some embodiments, the outersurface of the body 302 may be recessed by a depth approximately equalto the thickness of the expandable member material. In this manner, whenthe expandable member material is attached to the body 302, the outsideof the expandable member material is substantially aligned with theouter surface 310 of the distal cap 300. The material of the expandablemember 170 can be attached to the body 302 by a variety of methods,including, without limitation, adhesives such as cyano-acrylates orepoxies, crimping metallic rings over the expandable portion, meltbonding the expandable member to the body 302 with the use of heat(e.g., RF generated), ultrasonically welding the expandable member tothe body 302, or another method or combination of methods.

In reference to FIG. 8C, in some embodiments, the material of theexpandable member 170 may be attached to the inner surface of the body302 of the distal cap 300.

Optic Fibers

The light conducting fibers or optical fibers may include a singleoptical fiber or a plurality of light conducting fibers 140, wherein theoptical fibers may be positioned side-by-side or in parallel in theexpandable member 170 (see FIG. 1B and FIG. 1C). In an embodiment, aplurality of light conducting fibers 140 can be positioned serially withends of adjacent light conducting fibers 140 aligned or abutting onanother in an end to end fashion (see FIG. 1B and FIG. 1C). For example,one light conducting fiber may be positioned in the distal portion ofthe expandable member and another light conducting fiber may bepositioned in the proximal portion of the expandable member 170. In anembodiment, a plurality of light conducting fibers can be positioned ina combination of parallel and serial positions, such as partiallyoverlapping or any other suitable configuration. In an embodiment, aplurality of light conducting fibers can be attached to a single lightsource with a splitter, or can be attached to a plurality of lightsources.

The most basic function of a fiber is to guide light, i.e., to keeplight concentrated over longer propagation distances despite the naturaltendency of light beams to diverge, and possibly even under conditionsof strong bending. In the simple case of a step-index fiber, thisguidance is achieved by creating a region with increased refractiveindex around the fiber axis, called the fiber core, which is surroundedby the cladding. The cladding may be protected with a polymer coating.Light is kept in the “core” of the light-conducting fiber by totalinternal reflection. Cladding keeps light traveling down the length ofthe fiber to a destination. In some instances, it is desirable toconduct electromagnetic waves along a single guide and extract lightalong a given length of the guide's distal end rather than only at theguide's terminating face.

In an embodiment, an optical fiber of the present disclosure ismanufactured from a Lumenyte STA-FLEX® “SEL” END LIGHT OPTICAL FIBER,available from Lumenyte International Corporation of Foothill Ranch,Calif., can be employed. These optical fibers may each consist of alight transmitting solid large core, a Teflon® clad and a black bondableouter jacket. The optical fiber may transmit light from a light sourceto the distal tip for use as a point source. The optical fiber may havea wide 80 degree acceptance angle and 80 degree beam spread, allowingthe light to be viewed from more oblique angles. The light transmittingcore may be solid, may have no light diminishing packing fraction lossesand may be easily spliced. The jacket may be bondable. Custom jacketsmay be available for more flexibility and color options. The opticalfiber can each have a transmission loss (attenuation) of less thanapproximately 1.5% per foot, a bend radius (minimum) of approximately 6times the fiber's diameter, temperature stability of up to approximately90° C. (194° F.), spectral transmission range of approximately 350-800nm, an acceptance angle of approximately 80°, a refractive index core ofapproximately 1.48 or greater, cladding of approximately 1.34 or lessand a numerical aperture of approximately 0.63. The length of theoptical fiber can be approximately 100 continuous feet. Splicing may beachieved in the field using a splice kit, such as the Lumenyte SpliceKit, and carefully following the instructions. Factory splicing may bean option. An optic cutter, such as Lumenyte's Optic Cutter, may beadvised for straight, clean, 90° fiber cuts. These fibers may beinstalled by removing approximately 4 inches (10 cm) of the outer jacket(not the fluoropolymer cladding) before inserting fiber into the lightsource. An end of the fiber may be near, but not touching theilluminator (light source) glass to assist in achieving maximumbrightness.

In an embodiment, an optical fiber of the present disclosure ismanufactured from a ESKA™ High-performance Plastic Optical Fiber: SK-10and SK-60 and/or ESKA™ Plastic Fiber Optic & Cable Wiring, manufacturedby Mitsubishi Rayon Co., Ltd., which are all available from MitsubishiInternational Corporation of New York, N.Y. These optical fibers mayeach consist of a light transmitting PMMA (polymethylmethacrylate) coreand a fluorinated polymer as the cladding. It should be appreciated thatthe above-described characteristics and properties of the optical fibersare exemplary and not all embodiments of the present invention areintended to be limited in these respects.

In some embodiments, optical elements may be oriented in alignment withthe notches, cuts or openings in the nonlinear light-emitting portion ofan optical fiber of the present disclosure to adjust the light output.Such optical elements may include lenses, prisms, filters, splitters,diffusers and/or holographic films. The light source, and morespecifically, the optical fibers may have some or all of the propertiesand features listed in U.S. Pat. No. 6,289,150, which is herebyincorporated by reference in its entirety, as not all embodiments of thepresent invention are intended to be limited in these respects.

One or more optical elements, such as diffusers, polarizers, magnifyinglenses, prisms, holograms or any other element capable of modifying thedirection, quantity or quality of the illumination, individually or incombination can also be added and aligned with the core-clad, notchesand channel, track or holder and/or reflector.

Further, the implant may be designed to amplify light to the surroundingareas using one of reflective prisms within, Fresnel lens, Magnificationlens on the surface, shapes to the external form of the implant that aredesigned to magnify/amplify the light transmission.

Customized Cuts Along Optical Fiber to Align with Channel Configurationsto Maximize Light Amplification

FIG. 9 shows an embodiment of an optical fiber 306 of the presentdisclosure fabricated from a flexible light transmitting material thatcan be inserted into at least one channel. The optical fiber 306includes a hub 250 at a proximal end for attaching to a light source(either directly or indirectly, for example, through the use of anattachment system, see FIG. 1). The optical fiber 306 includes a linearelongated portion 248 for guiding light towards a nonlinearlight-emitting portion, generally referred to as 258, which emits lightfrom the outside of the fiber along its length. The nonlinearlight-emitting portion 258 can be any length suitable for a givenapplication. The distal tip of the optical fiber 306 may also emit lightcreating a small spotlight effect. In an embodiment, the optical fiber306 also includes a flexible strain relief 252 just to the right of thehub 250 and a depth stop 254. In an embodiment, the strain relief 252prevents snapping of the optical fiber 306 at the hub 250 junction. Inan embodiment, the strain relief 252 and the depth stop 254 are madefrom a flexible material. In an embodiment, the strain relief 252 andthe depth stop 254 are made from Santoprene™, a thermoplastic rubber.FIG. 9 shows the optical fiber 306 in an elongated stretched conditionand being in a “temporary” shape. In the temporary shape, the nonlinearlight-emitting portion 258 is stretched and assumes a linearconformation in which the nonlinear light-emitting portion 258 of theoptical fiber 306 can be advanced through the inner lumen of theelongated shaft of the balloon catheter 110.

As illustrated in FIG. 9, for example, according to an embodiment, ahelical design may be provided that includes cuts at a most proximalportion of the light-emitting portion that are spread farther apart thancuts at a most distal portion of the light-emitting portion. Typically,when an optical fiber is attached to a light source that is “on”, thecuts at the proximal portion of the light-emitting portion will emitlight that looks brighter than the cuts at the distal portion of thelight-emitting portion when in at least one channel.

The optical fiber may include a non-shape memory optical fiber or ashape memory optical fiber depending on the application relating to oneor more channels or not relating to one or more channels located withinor on the outer surface (i.e. within ridges) of the expandable member.For example, it may desirable to provide shape memory to thelight-emitting portion of an optical fiber of the present disclosure soas to conform to a shape of at least one channel. In some embodiments,the shape memory can be imparted to the light-emitting portion usingconventional techniques known in the art. By way of a non-limitingexample, a distal length of an optical fiber of the present disclosuremay first be heat treated to provide stress relief, that is, to removeany shape memory from the optical fiber induced into the optical fiberduring the manufacturing process. Heat treatment can also be used toinduce a pre-set into the optical fiber. The distal length of thestress-relieved optical fiber may then be wound around a circularmandrel to provide the distal length with a desired shape. Next, themandrel with the coiled optical fiber can be subjected to heat treatmentto induce the desired shape and then quenched to set the desired shapeinto the optical fiber. In an embodiment, the optical fiber may be heattreated using a water bath.

FIG. 10 shows a view of another embodiment of a distal end of a ballooncatheter of the present disclosure, which is similar to FIG. 3, whereinthe optical fiber 306 has a pre-defined shape specific to the shape ofthe channel 303A. Wherein the optical fiber 306 can be incorporatedwithin the elongated shaft of the balloon catheter and encircle theinner surface 330 of the expandable balloon 303A within the channel303A.

The nonlinear light-emitting portion can be any given length suitablefor a given application. For example, a nonlinear light-emitting portionof an optical fiber of the present disclosure can have a length rangingfrom about 60 mm to about 300 mm, 60 mm to about 400 mm, 60 mm to about500 mm or 60 mm to about 600 mm. It is contemplated the optical fibermay be shaped to incorporate a single loop to extend an entire length ofthe channel 303A or only partially extend the entire length of thechannel 303A.

It is possible illuminators may be made in the optical fiber core alonebefore the cladding is added and/or the illuminators may be made in thecladding and the core after it has been surrounded by the cladding. Insome embodiments, when the cladding is heated to tightly shrink aroundthe core, the cladding may affect the uniformity of the illuminators inthe core by either entering the notch or closing the cut therebyreducing the potential light deflecting properties of the illuminator.

The illuminators may be positioned to direct light across the greaterdiameter of an elliptical optical fiber core out and out through aregion opposite from each of the respective illuminators. This may beaccomplished by angling the notches and/or cuts to direct light from thelight source through the optic core. The illuminators allow bettercontrol of escaping light by making the notches, which are positioned onone side of the optic to direct the light rather than allowing the cutsto reflect/refract light in various directions which reduces thecontribution of light to a desired focusing effect.

In an embodiment, the total light output from a nonlinear light-emittingportion of the present disclosure having a length of about 100 mm is thesame as a nonlinear light-emitting portion of the present disclosurehaving a length of about 300 mm. In an embodiment, the total lightoutput required for the nonlinear light-emitting portion of an opticalfiber of the present disclosure is about 10 μW/cm², 20 μW/cm², 30μW/cm², 40 μW/cm², 50 μW/cm² or 60 μW/cm².

In some embodiments, the optical fiber may include an optical fiber coresurrounded by cladding material and one or more illuminators. Theilluminators may be of uniform size and shape positioned in apredetermined, spaced-apart relation, linearly, along a side of theoptical fiber core. The optical fiber core may be received in a trackand/or holder and/or reflector comprising a channel constructed with areflective interior surface centered about the illuminators. The holderand/or reflector may be positioned adjacent to or in contact with theplurality of illuminators.

Methods of Delivering Light to Cavities of the Bone to Provide for anAnti-Microbial Effect

FIG. 11A, FIG. 11B, FIG. 11C, FIG. 11D and FIG. 11E provide embodimentmethods for delivering light and/or implanting an intramedullary implantof the present disclosure within the intramedullary space of a weakenedor fractured bone. A minimally invasive incision (not shown) may be madethrough the skin of the patient's body to expose a fractured bone 1102.The incision may be made at the proximal end or the distal end of thefractured bone 1102 to expose the bone surface. Once the bone 1102 isexposed, it may be necessary to retract some muscles and tissues thatmay be in view of the bone 1102. As shown in FIG. 11A, an access hole1110 may be formed in the bone by drilling or other methods known in theart. In some embodiments, the access hole 1110 has a diameter of about 4mm to about 7 mm. In some embodiments, the access hole 1110 has adiameter of about 9 mm.

The access hole 1110 extends through a hard compact (cortical) outerlayer 1120 of the bone into the relatively porous inner or cancelloustissue 1125. For bones with marrow, the medullary material should becleared from the medullary cavity prior to insertion of the inventivedevice. Marrow is found mainly in the flat bones such as hip bone,breast bone, skull, ribs, vertebrae and shoulder blades, and in thecancellous material at the proximal ends of the long bones like thefemur and humerus. Once the medullary cavity is reached, the medullarymaterial including air, blood, fluids, fat, marrow, tissue and bonedebris should be cleared or loosened to form a void. The void is definedas a hollowed out space, wherein a first position defines the mostdistal edge of the void with relation to the penetration point on thebone, and a second position defines the most proximal edge of the voidwith relation to the penetration site on the bone. The bone may behollowed out sufficiently to have the medullary material of themedullary cavity up to the cortical bone removed. There are many methodsfor removing the medullary material that are known in the art and withinthe spirit and scope on the presently disclosed embodiments. Methodsinclude those described in U.S. Pat. No. 4,294,251 entitled “Method ofSuction Lavage,” U.S. Pat. No. 5,554,111 entitled “Bone Cleaning andDrying system,” U.S. Pat. No. 5,707,974 entitled “Apparatus forPreparing the Medullary Cavity,” U.S. Pat. No. 6,478,751 entitled “BoneMarrow Aspiration Needle,” and U.S. Pat. No. 6,958,252 entitled“Apparatus for Extracting Bone Marrow.”

A guidewire (not shown) may be introduced into the bone 1102 via theaccess hole 1110 and placed between bone fragments 1104 and 1106 of thebone 1102 to cross the location of a fracture 1105. The guidewire may bedelivered into the lumen of the bone 1102 and may cross the location ofthe break 905 so that the guidewire spans multiple sections of bonefragments. As shown in FIG. 11B, the expandable member 170 of thedelivery catheter 101 for repairing a fractured bone, which isconstructed and arranged to accommodate the guidewire, is delivered overthe guidewire to the site of the fracture 1105 and spans the bonefragments 1104 and 1106 of the bone 1102.

In some embodiments, it is contemplated that at least one optical fiberor other light source may be introduced into the bone for a period oftime prior to placing the expandable member 170 within the cavity of thebone to provide for an anti-microbial effect. That is, in someembodiments, the bone 1102, the cavity 1110, and/or the surroundingtissue can be pre-illuminated to substantially sterilize the repair siteprior to introduction of the expandable member. In some embodiments,because the pre-illumination light source does not need to pass throughthe balloon catheter 110, the pre-illumination light source canadvantageously be a larger, higher-powered light source than thein-process light source for greater initial anti-microbial effect.

In some embodiments, the guidewire can be placed by use of a splitsheath and dilator (not shown). In some embodiments, the split sheathand dilator can include an outer tube-shaped sheath and an inner dilatorextending coaxially through the sheath. In some embodiments, the innerdilator can include a passageway sized and shaped for passing theguidewire therethrough. In some embodiments, the guidewire, the sheath,and/or the dilator can include at least one optical fiber or other lightsource for illuminating the repair site. In some embodiments, thesheath, the dilator, and/or the guidewire can thereby be used topre-illuminate the repair site, illuminate the repair site duringinstallation of the expandable member 170, and/or to illuminate therepair site during curing and hardening of the expandable member 170.Thus, by providing light source integrated within the sheath, dilator,and/or guidewire, a duration of the illumination of the repair site canbe increased, thereby improving the anti-microbial effect.

Once the expandable member 170 is in place, the guidewire may beremoved. The location of the expandable member 170 may be determinedusing at least one radiopaque marker 1190 which is detectable from theoutside or the inside of the bone 1102. Once the expandable member 170is in the correct position within the fractured bone 1102, a deliverysystem which contains optical fiber(s) passes light from a light sourcethrough the first port 162, through the inner lumen of the elongatedshaft of the balloon catheter 110, through the distal end 104 of theballoon catheter 110, through the inner lumen of the expandable memberand into the cavity of the bone. It is contemplated the optical fiber(s)may pass through a channel located within the expandable member. It isalso possible the optical fiber(s) may pass through a manifold locatedin the inner lumen of the expandable member and then into a channellocated within the expandable member. It is possible for the opticalfiber(s) to enter a channel located within a ridge positioned on anouter surface of the expandable member.

It is possible for radiopaque markers and guides to provide alignmenttowards steering the user towards a correct position. Further, the endof the implant may have a longer inner tube and light guide receptaclethat is longer than the implant and extends several inches beyond.Further still, this end could be left attached to the implant and buriedsubcutaneously and sealed, so that when and, if needed, the end wasexposed via a small incision, the rolled tube exposed and the lightfiber introduced would all make for the delivery to be easier.

Once the optical fiber(s) is positioned within the cavity of the bone,the optical fiber(s) is capable of providing for an anti-microbialeffect, either prior to, during the delivery of the light-sensitiveliquid, or after the light-sensitive liquid has been cured and hardened.It is contemplated the optical fiber(s) may provide for an antimicrobialeffect while light-sensitive liquid is infused through the inner void210 in the delivery catheter 101 and enters the inner cavity 295 of theexpandable member 170.

After the expandable member 170 is in the correct position within thefractured bone 1102, a delivery system which contains a light-sensitiveliquid is attached to the port 195. The light-sensitive liquid is theninfused through the inner void 210 in the delivery catheter 101 andenters the inner cavity 295 of the expandable member 170. This additionof the light-sensitive liquid within the expandable member 170 causesthe expandable member 170 to expand, as shown in FIG. 11C. As theexpandable member 170 is expanded, the fracture 1105 is reduced. Unliketraditional implants, such as rods, that span the fracture site, theexpandable member 170 of the present disclosure does more than providelongitudinal strength to both sides of the fractured bone. In someembodiments, the expandable member 170 having the design can be a spacerfor reducing the fracture and for holding the fractured and compressedbones apart at the point of the collapsed fracture.

Once orientation of the bone fragments 1104 and 1106 are confirmed to bein a desired position, the light-sensitive liquid may be hardened withinthe expandable member 170, as shown in FIG. 11D, such as by illuminationwith a visible emitting light source. In some embodiments, during thecuring step, a syringe housing a cooling media may be attached to theproximal end of the delivery catheter and continuously delivered to theexpandable member 170. The cooling media can be collected by connectingtubing to the distal end of the inner lumen and collecting the coolingmedia via the second distal access hole. After the light-sensitiveliquid has been hardened, the light source may be removed from thedevice. Alternatively, the light source may remain in the expandablemember 170 to provide increased rigidity.

In some embodiments, subsequent illumination of the bone 1102 andsurrounding tissue of the repair site can be performed after theexpandable member 170 has been hardened. In some embodiments, where thelight source has been removed from the expandable member 170, suchsubsequent illumination can be performed by reintroducing the lightsource into the hardened expandable member 170 and activating the lightsource. In some embodiments, where the light source has been removedfrom the expandable member 170, such subsequent illumination can beperformed by positioning a light source adjacent to the hardenedexpandable member 170 and directing illumination into the expandablemember 170 for distribution throughout the repair site. In someembodiments, where the light source remains in the expandable member 170(e.g., to provide rigidity as discussed above), the light source can bereactivated to illuminate the repair site. In some embodiments,reactivation of the remaining light source can include reconnecting thelight source to an external power or light generating device. In someembodiments, the remaining light source can include a power source(e.g., batteries) for remote activation as-needed. In some embodiments,the remaining light source can include inductive circuitry for example,for inductively activating the light source and/or for inductivelycharging batteries of the light source.

FIG. 11E shows at least one embodiment of a bone fixation device in acavity of a bone after being separated from an introducer. For example,the expandable member 170 once hardened, may be released from thedelivery catheter 101 to form a photodynamic bone fixation device insidethe intramedullary cavity of the bone 1102. It is contemplated thatoptical fiber(s) may be passed in an inner lumen of the photodynamicbone fixation device, and optionally pass through a manifold locatedwithin the inner lumen and into a channel located in the photodynamicbone fixation device. Further, it is possible optical fiber(s) may bepassed in a channel located within a ridge positioned on an outersurface of the photodynamic bone fixation device. Once the opticalfiber(s) are positioned with the cavity of the bone, the opticalfiber(s) may provide for an anti-microbial effect.

The following paragraphs provide experiments regarding the presentdisclosure relating to killing of orthopaedic relevant pathogens usingblue light.

Overview

It is believed that blue light with wavelengths outside of the UVspectrum can have antimicrobial properties for both Gram-negative andGram-positive bacteria. Currently, a clinical trial using blue light forphotodynamic bone stabilization has begun, in accordance with aspects ofthe present disclosure. The question of whether the blue light used forphotodynamic bone stabilization could kill orthopaedic relevant bacteriawas asked because one of the major outputs from the optical fiber at 405nm (see FIG. 12) has been shown to eradicate methicillin-resistant. FIG.12 shows the output (Blue), positive control (405 nm—orange), positivecontrol (470 nm—gray). The box area highlights the wavelengths of light(405 nm to 470 nm) that has shown to be antimicrobial againstorthopaedic relevant bacteria. The blue light has a major peak in theregion of 405 nm.

Null Hypothesis

Blue light is not capable of bactericidal activity against orthopaedicrelevant bacteria because it does not have enough energy to bebacterial.

Objective

Using suspension cultures, we will test the following: (1) DoesIlluminOss light kill MSSA and MRSA in a time dependent manner? (2) DoesIlluminOss light kill patient isolated bacterial from orthopaedicinfections? and (3) Does the IlluminOss implant have bactericidalactivity during the time required for intra-operative polymerization(about 15 minutes)?

Significance

It is possible blue light may indicate that broad-spectrum antimicrobialeffects that can be generated for both Gram-negative and Gram-positivebacteria. The antimicrobial effect may be due to bacteria intracellularporphyrins and the production of cytotoxic reactive oxygen molecules.Light in the visible spectrum may have the most effective wavelength forantimicrobial effects with the region of 402-420 nm, which appear to bemost promising. It is encouraging that one of the major peaks foremission is in this blue light region (see FIG. 12). However, the bluelight inactivation of bacteria may be dependent on dose. The dose oflight needed to be bactericidal may be determined by an equation E=Pt,where E is in J/cm², P is in mW/cm² and t is time in seconds. It wasdetermined from previous studies that a dose of 36 J/cm2 is toxic tobacteria but not harmful to mammalian cells.

Initial suspension culture experiments were conducted demonstrating atime-dependent killing of MSSA with the light at energy levels that arenot toxic to mammalian cells (see FIG. 13A and FIG. 13B). Furthertesting will allow for further characterization of this effect onpatient isolated from orthopaedic infections and to test the potentialbactericidal effect during a 15 minute implant curing process.

Research Design and Method

Suspension cultures have been used to determine the effect of blue lighton bacterial inactivation. We have used this method to study the effectof IlluminOss blue light on MSSA ATCC 29213. The bacterial strain wasdiluted in 0.9% NSS until reaching an optical density of 0.5 McFarlandunits (1.5×10⁸ CFU/ml). Initial experiments were completed to determinethe correct serial dilution in NSS to obtain about 200 colonies per 100ul inoculum onto 100 mm blood agar plates (see FIG. 13A and FIG. 13B forcolony counts). After final dilutions to a concentration that isrelevant to cause orthopaedic related infections (around 10⁵), 3 ml ofbacterial suspension was used for the light dosing experiments. A “endfire” fiber optic cable and R&D light box were included and then theintensity of light emitted from the end of the fiber optic cable to be17.4 mW/cm² in the wavelengths from 395-415 nm was calculated. This “endfire” cable was used for the dosing experiments.

From a distance of 2 cm above the suspension culture surface the “endfire” IlluminOss light was delivered to the culture. 100 ul samples weretaken after vortexing at 0, 5, 10, 15, 20, 25 and 30 minutes ofcontinuous light treatment with duplicate experiments performed. The 100ul bacterial suspension samples were streaked onto 100 mm blood agarplates and immediately placed into an incubator for 24 hrs at 37° C. at5.5% CO₂. After 24 hrs the plates had colonies counted and datapresented as % kill over time. Several controls were used including a 30minute control of bacterial suspension in the 0.9% NSS with plating andcolony counts that were not different from the 0 minute controlindicating no effect of diluent over time. Additionally, since lightgenerates heat the bacterial suspension cultures had direct temperaturemeasurements. This did show that the suspensions increased from roomtemperature to 26.2° C. during the 30 minute treatment time indicatingthat the decrease in colony counts were not due to temperature effects.Initial experiments were done in a hospital microbiological laboratory.

It is noted the implant takes 15 minute for the polymerization step. Itis therefore encouraging that the data in FIG. 13A and FIG. 13B indicatea bactericidal effect within this timeframe. The experiment showed tokill orthopaedic relevant bacteria.

FIG. 14A, FIG. 14B, FIG. 14C, and FIG. 14D show the initial experimentalset up. FIG. 14E indicates heat generation issues with change to opticalfiber (POF). FIG. 14F indicates the identified wavelength viaexperimentation is about 405 nm. FIG. 14G indicates through results ofexperimentation that blue light works to have an anti-microbial effecton bones.

FIG. 15A, FIG. 15B, FIG. 15C, FIG. 15D, FIG. 15E, FIG. 15F, FIG. 15G,FIG. 15H, FIG. 15I, FIG. 15J, FIG. 15K, FIG. 15L, FIG. 15M, FIG. 15N,FIG. 15O, and FIG. 15P show the optical fiber (POF) experimental set up.FIG. 15A and FIG. 15B indicate the Oct. 18, 2015 trial that included:MISSA, ATCC29213, dilution in NSS, 3 cm distance from optical fiber(POF), 5, 10, 15, 30, 45 and 60 minute time. Plating over time of 100ul, blood agar. FIG. 15C shows patient isolated cultures treated withblue light. FIG. 15D shows a graph resulting in a 100 percent kill rateof MSSA with a device.

FIG. 15E and FIG. 15F indicate the Oct. 20, 2015 trial that included:MISSA, ATCC29213, dilution in NSS, 2 cm distance from the optical fiber(POF), 5, 10, 15, 20, 25 and 30 minute time. Plating over time of 100ul, blood agar and additional control. FIG. 15G shows patient isolatedcultures treated with blue light. FIG. 15H shows a graph resulting in astaph aureus kill rate over time. FIG. 15I and FIG. 15J show the percentdecrease in colony counts versus time.

FIG. 15K and FIG. 15L indicate the Oct. 23, 2015 trial that included:Patient isolate MRSA, dilution in NSS, 2 cm distance from the opticalfiber (POF), 5, 10, 15, 20, 25 and 30 minute time. Plating over time of100 ul, blood agar and additional control. FIG. 15M shows patientisolated cultures treated with blue light. FIG. 15N and FIG. 15Oindicate the optical fiber (POF) kills MSSA and MRSA. The POF experimentprovided light delivered by the optical fiber (POF) that is bactericidalat clinically relevant times to clinically relevant bacteria. It isnoted that completed experiments were in the “right” energy delivery inJ/cm² at 405 nm. Finally, wound healing is NOT affected by bluelight—(HINS light 5 mW/cm² for 1 hour no effect on fibroblast function).FIG. 15P shows patient isolated cultures treated with blue light.

Referring to FIG. 16A, FIG. 16B and FIG. 16C show an intraoperativestabilization of a humerus fracture showing the blue light output. FIG.16A is a graph that shows the spectral output from the fiberoptic cableused in the device. FIG. 16B and FIG. 16C show the blue light outputfrom the site of humeral biopsy.

According to aspects of the disclosure, the use of blue light may killMRSA, such that the blue light can provide sterilization oforthopaedically relevant pathogenic bacteria, among other things. Forexample, blue light, with wavelengths outside of the UV spectrum, canhave antimicrobial properties for both Gram-negative and Gram-positivebacteria (using blue light for photodynamic bone stabilization,inventor's light fix clinical trial at Marshall University IRB 704603).It is possible, by non-limiting example this antimicrobial effect can bedue to bacteria intracellular porphyrins and the production of cytotoxicreactive oxygen molecules, among other things.

Referring to FIG. 16A, the box area highlights the wavelengths of light(405-470 nm) in accordance with aspects of the disclosure. Inparticular, the wavelengths of light (405-470 nm) show it is possiblefor antimicrobial effects against orthopaedic relevant bacteria.Further, one of the blue light outputs from the optical fiber at 405 nm(see FIG. 16A, blue peak in yellow oval), show that this wavelength caneradicate methicillin-resistant S. aureus (MRSA), S. aureus and P.aeruginosa in a time and dose dependent manner due to the production ofcytotoxic reactive oxygen molecules. Further, according to aspects ofthe disclosure, it is determined that the full spectrum light outputduring the 400 second implant curing process is capable of bactericidalactivity to orthopaedically relevant pathogens.

FIG. 17A and FIG. 17B show patient isolated MRSA suspension culturestreated with blue light from an implant 9×160 mm with curing occurringat 400 seconds. FIG. 17A shows a graph of the number of the patientisolated MRSA culture counts versus time in seconds curing with the bluelight. FIG. 17B shows the percent decrease in colony counts versus timein seconds curing with the blue light. FIG. 17A (top) and FIG. 17B(bottom) illustrates that 99.9% of bacteria is killed during the 400seconds curing of the implant. Wherein an the additional time point at800 seconds shows 100% inactivation of MRSA.

FIG. 17A shows time dependent inactivation of MRSA (samples taken atevery 400 seconds) seen after plating 100 ul onto 100 mm blood agarplates and incubating for 24 hrs at 37° C. at 5.5% CO₂. FIG. 17B shows99.9% of bacteria killed during the 400 seconds curing of the implant.An additional time point at 800 seconds is shown with 100% inactivationof MRSA. It is noted that temperature measurements were never above26.2° C. indicating no bacterial inactivation due to heat.

According to methods of the disclosure, blue light inactivation ofbacteria can be dependent on amount or dose of light as described by theequation:

Energy (J/cm2)=Intensity (W/cm2)×time (seconds)

Wherein, it is noted that a dose of 36 J/cm2 is toxic to bacteria butnot harmful to mammalian cells. It is possible to use suspensioncultures to determine the effect of blue light on bacterialinactivation, wherein this method was used to study the effect of bluelight on control bacteria, i.e. MSSA (ATCC 29213) and MRSA (ATCC 43300).Further, according to aspects of the disclosure the bacterial strain wasdiluted in 0.9% NSS until reaching an optical density of approximately0.5 McFarland units (1.5×10⁸ CFU/ml). Initial experiments were completedto determine a correct serial dilution in NSS to obtain about 200colonies per 100 ul inoculum onto 100 mm blood agar plates. After finaldilutions to a concentration that is relevant to cause orthopaedicrelated infections (around 10⁵), 3 ml of bacterial suspension was usedfor the light dosing experiments. A time-depending bacterial killing wasnoted in these control experiments (data not shown). These suspensionculture experiments were repeated in duplicate for patient isolated MRSAand data shown in FIG. 17A and FIG. 17B. FIG. 17B shows that a 99.9%killing of MRSA was obtained in 400 seconds used for curing at energylevels that are not toxic to mammalian cells.

According to aspects of methods and embodiments of the disclosure, MRSAis 99.9% inactivated during the 400 seconds cure for the disclosedimplant. It is noted that the aspects of the disclosure of bactericidalactivity associated with an Orthopaedic Implant that is not due to theintrinsic material properties of the implant. According to aspects ofthe disclosure, it is contemplated that the effectiveness of implant onbacterial pathogens most commonly causing Orthopaedically relevantinfections can be a way to minimize or manage surgical site infections.It is possible aspects of the disclosure can be used for decontaminationof wounds, implants, infected bone and environmental and biologicallycontaminated surfaces, among other things.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that several of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or applications.

1-20. (canceled)
 21. A system for providing treatment to bone,comprising: a delivery catheter having an elongated shaft and an innerlumen therethrough; and one or more optical fibers sized to pass throughthe inner lumen of the delivery catheter and being configured todirectly deliver light energy to provide site-specific bone treatment ofone or more pathogens, wherein the direct delivery of light energycreates molecular oxygen for treating the one or more pathogens.
 22. Thesystem of claim 21, wherein the light energy is delivered for about 400seconds to provide the site-specific bone treatment.
 23. The system ofclaim 21, wherein the light energy is delivered for between about 400seconds and about 800 seconds to provide the site-specific bonetreatment.
 24. The system of claim 21, wherein the light energy isdelivered having a wavelength from about 380 nm to about 500 nm toprovide the site-specific bone treatment.
 25. The system of claim 21,wherein the light energy is delivered having a wavelength from about 400nm to about 420 nm to provide the site-specific bone treatment.
 26. Thesystem of claim 21, wherein the site-specific bone treatment isconfigured to kill the one or more pathogens.
 27. A system for providingtreatment to a bone, comprising: a delivery catheter having an elongatedshaft and an inner lumen therethrough; and one or more optical fiberssized to pass through the inner lumen of the delivery catheter and beingconfigured to directly deliver light energy to provide site-specifictreatment of a bone infection, wherein the direct delivery of lightenergy creates molecular oxygen for treating the bone infection.
 28. Thesystem of claim 27, wherein the light energy is delivered for about 400seconds to provide the site-specific treatment.
 29. The system of claim27, wherein the light energy is delivered for between about 400 secondsand about 800 seconds to provide the site-specific treatment.
 30. Thesystem of claim 27, wherein the light energy is delivered having awavelength from about 380 nm to about 500 nm to provide thesite-specific treatment.
 31. The system of claim 27, wherein the lightenergy is delivered having a wavelength from about 400 nm to about 420nm to provide the site-specific treatment.
 32. The system of claim 27,wherein the site-specific bone treatment is configured to kill the boneinfection.
 33. A method for treating a bone, comprising: delivering acatheter to a bone; delivering one or more optical fibers through thecatheter to the bone; activating a light source engaging the one or moreoptical fibers; and delivering light energy from the light source to theone or more optical fibers to provide site-specific treatment of one ormore pathogens, wherein the delivery of light energy creates molecularoxygen for treating the one or more pathogens.
 34. The method of claim33, wherein the light energy is delivered for about 400 seconds toprovide the site-specific treatment.
 35. The method of claim 33, whereinthe light energy is delivered for between about 400 seconds and about800 seconds to provide the site-specific treatment.
 36. The method ofclaim 33, wherein the light energy is delivered having a wavelength fromabout 380 nm to about 500 nm to provide the site-specific treatment. 37.The method of claim 33, wherein the light energy is delivered having awavelength from about 400 nm to about 420 nm to provide thesite-specific treatment.
 38. The system of claim 33, wherein thesite-specific bone treatment is configured to kill the one or morepathogens.